Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months

NCT03704740 | Completed Phase 3 DMC

• 1 other identifier: NBP607-QIV_005
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

Conditions

Influenza

Outcome Measures

Primary Outcomes (4)

• Post-vaccination GMT(Geometric Mean Titer) by HI(Hemagglutination-inhibition) assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)

  Post-vaccination GMT will be adjusted for pre-vaccination titer

  4 weeks after last IP(Investigational Product) vaccination

• Seroconversion rate by HI assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)

  Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria: 1. Post-vaccination HI titer of ≥1:40 for subjects with pre-vaccination HI titer of \<1:10 2. Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥1:10

  4 weeks after last IP(Investigational Product) vaccination

• Seroconversion rate by HI assay for the exclusive strain (B/Yamagata)

  Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria: 1. Post-vaccination HI titer of ≥1:40 for subjects with pre-vaccination HI titer of \<1:10 2. Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥1:10

  4 weeks after last IP(Investigational Product) vaccination

• GMR(Geometric mean ratio) by HI assay for the exclusive strain (B/Yamagata)

  The fold-rise of the geometric mean HI titer from pre- to post-vaccination

  4 weeks after last IP(Investigational Product) vaccination

Secondary Outcomes (7)

• Seroprotection rate by HI assay for all strains

  4 weeks after last IP(Investigational Product) vaccination

• CHMP(Committee for Medicinal Products for Human Use) criteria assessment for the common strains (A/H1N1, A/H3N2, and B/Victoria)

  4 weeks after last IP(Investigational Product) vaccination

• Consistency of immunogenicity among countries

  4 weeks after last IP(Investigational Product) vaccination

• Percentage of participants with Adverse Events(AEs)

  7 days for Solicited AE and 4 weeks for Unsolicited AE, SAE after last IP(Investigational Product) vaccination

• Vital sign

  4 weeks after last IP(Investigational Product) vaccination

Study Arms (2)

NBP607-QIV

EXPERIMENTAL

One or two doses of 0.5mL of NBP607-QIV by intramuscular injection

Biological: NBP607-QIV

Agrippal

ACTIVE COMPARATOR

One or two doses of 0.25mL of Agrippal by intramuscular injection

Biological: Agrippal

Interventions

NBP607-QIV BIOLOGICAL

Purified inactivated influenza virus surface antigens of four strains (quadrivalent)

NBP607-QIV

Agrippal BIOLOGICAL

Influenza virus surface antigens of three strains (trivalent)

Agrippal

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 35 months
• Those who were normal gestational age at birth (for children aged 6 months to \<1 year)
• Those who have provided written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study

You may not qualify if:

• Those with any immunodeficiency disease or malignancy
• Those with hypersensitivity to vaccination
• Those who are contraindicated for intramuscular injection due to thrombocytopenia or other coagulopathy
• Those with history of treatment with any of immunosuppressants or immunoregulators within 12 weeks prior to screening
• Those with history of receiving blood product or treatment with immunoglobulin within 24 weeks prior to screening
• Those with history of influenza vaccination within 24 weeks prior to screening
• Those with any severe chronic conditions that interfere with study participation

Sponsors & Collaborators

• SK Bioscience Co., Ltd.: lead

Study Sites (1)

SK Bioscience

Gyeonggi-do, Seongnam-si, 13494, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Yun Kyung Kim, MD

  Korea University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: October 25, 2018
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)